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You can replay our live webcast here on the STENOVA OLE results on October 1 at 8:30 am EST / 2:30 pm CET.

PR

Agomab Reports Positive Topline Data from STENOVA Open-Label Extension Study of Ontunisertib in Fibrostenosing Crohn's Disease

  • Favorable safety and tolerability profile maintained through up to 60 weeks of treatment with ontunisertib in Fibrostenosing Crohn’s disease (FSCD) patients
  • Low annualized FSCD-related event rate of 3%, with one endoscopic balloon dilation (EBD) and no surgeries reported over the full treatment period
  • Radiological assessment shows trend for fibrotic stricture stabilization over treatment course
  • Sustained disease control observed across symptoms and disease activity scores in Open-Label Extension Study (OLE)
  • Results support initiation of global NOV-ERA Phase 2b study in FSCD in the coming months
  • Company to host webcast today at 8:30 a.m. Eastern Time

Antwerp, Belgium, October 1, 2026 – Agomab Therapeutics NV (‘Agomab’) a clinical-stage biopharmaceutical company focused on fibro-inflammation, today announced positive results of the 48-week OLE portion of the Phase 2a STENOVA trial evaluating ontunisertib in patients with FSCD, a severe manifestation of Crohn’s disease characterized by progressive bowel fibrosis and intestinal strictures.
The OLE study (Part B) evaluated long-term treatment with ontunisertib 200 mg BID on top of standard of care. Of the participants eligible to roll over into the OLE study from the 12-week placebo-controlled Part A of STENOVA, 94% elected to enter the study (n=49).
The results demonstrated a generally favorable long-term safety and tolerability profile of ontunisertib 200 mg BID for up to 60 weeks of treatment, as well as maintenance of the gut-restricted pharmacokinetic (PK) profile observed in Part A of the trial. Sustained disease control, with low symptoms and disease activity scores and radiological stricture stabilization, was also observed. Importantly, a low FSCD-related annualized event rate of 3% was reported in patients treated with ontunisertib 200 mg BID up to 60 weeks.

PR

Agomab Announces Positive Phase 1 Results for AGMB-447 in Patients with Idiopathic Pulmonary Fibrosis and Design of Phase 2 INSPIRIA Study

  • Topline Phase 1 data shows generally favorable safety and tolerability profile of AGMB-447
  • Pharmacokinetic profile confirms efficient lung restriction with low systemic exposure and high exposure of AGMB-447 in the lung, in line with prior results observed in healthy participants
  • Robust target engagement of ALK5 observed with AGMB-447 in IPF patients
  • Clinical Trial Application (CTA) for INSPIRIA Phase 2 study in IPF patients submitted; Company intends to initiate study before year-end

Antwerp, Belgium, September 14, 2026 – Agomab Therapeutics NV (‘Agomab’), a clinical-stage biopharmaceutical company focused on fibro-inflammation, today announced positive results of the Phase 1 study of AGMB-447 in IPF patients. AGMB-447 is an investigational inhaled lung-restricted small molecule inhibitor of ALK5 (or TGFβR1) intended for the treatment of Idiopathic Pulmonary Fibrosis (IPF).

PR

Agomab Announces Appointments of Marino Garcia and Dr. Naimish Patel to Board of Directors

Antwerp, Belgium, September 11, 2026 – Agomab Therapeutics NV (Nasdaq: AGMB) (“Agomab” or the “Company”), a clinical-stage biopharmaceutical company focused on fibro-inflammatory diseases, today announced that shareholders approved all resolutions submitted for consideration at the Company’s Special and Extraordinary General Shareholders’ Meeting held on September 11, 2026. The approved resolutions included the appointments of Marino Garcia and Naimish Patel, M.D. as nonexecutive members of the Company’s Board of Directors and the proposed consolidation and split adjustment of outstanding pre-Initial Public Offering (IPO) warrants.

“Our goal is to improve the lives of patients with fibrotic diseases. We are aiming to build a leading company that combines transformative science with the commitment and passion of our experienced team, partners, and investors.”

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Tim Knotnerus, Chief Executive Officer